This invention relates to an expansile device for use in vascular access tracts and non-vascular tracts in the human body and method and more particularly for percutaneous occlusion of vascular access sites in the human body.
Percutaneous access to the blood vessels and organs of is the human body for diagnosis and treatment of disease processes has heretofore been accomplished.
Percutaneous vascular procedures are performed involving the coronary, peripheral and cerebral vasculature. These procedures include coronary and peripheral angiography, angioplasty, atherectomies, coronary retroperfusion and retroinfusion, cerebral angiograms, treatment of strokes, cerebral aneurysms and the like. Patients undergoing such procedures are often treated with anti-platelet drugs, anticoagulants such as heparin, thrombolytics, or a combination thereof, all of which interfere with coagulation making it more difficult for the body to seal a puncture site. Various devices and methods have heretofore been utilized, however, they all have had deficiencies, including the use of complicated devices and methods. In addition, difficulties are still encountered in obtaining good seals. There is therefore a need for a device and method for percutaneous access and occlusion of vascular access sites and other puncture sites and natural tracts in the human body which overcome the deficiencies of prior art devices and methods.
In general, it is an object of the present invention to provide an expansile or closure device and method for percutaneous access and occlusion of vascular access sites, other puncture sites and natural tracts involving various organs having lumens or cavities in the human body which will make possible a positive seal of the puncture site or tract promoting rapid healing of the puncture site or tract.
Another object of the invention is to provide a closure device and method of the above character which can be easily and reliably used.
Another object of the invention is to provide a closure device and method of the above character which permits easy placement of the device without measuring or sizing of the tract or device.
Another object of the invention is to provide a closure device and method of the above character which can be deployed or made operative with one maneuver or movement.
Another object of the invention is to provide a closure device and method of the above character which can be deployed and is effective in severely tortuous vessels.
Another object of the invention is to provide a closure device and method of the above character which enables continued substantially unobstructed blood flow during deployment and use of the closure device.
Another object of the invention is to provide a closure device and method of the above character in which no foreign body remains in the blood vessel.
Another object of the invention is to provide a closure device and method of the above character that permits early ambulation of patients and avoids prolonged bed rest.
Another object of the invention is to provide a closure device and method of the above character which reduces the risk of bleeding, formation of arteriovenous fistula, formation of pseudoaneurysm, thrombosis with distal embolization and infection.
Another object of the invention is to provide a closure device and method of the above character that reduces the risk of causing ischemia of an extremity.
Another object of the invention is to provide a closure device and method of the above character that is inexpensive, quick, safe, easy to use and is disposable.